Renal Impairment Study of PF-06700841

  • STATUS
    Recruiting
  • End date
    Dec 27, 2021
  • participants needed
    32
  • sponsor
    Pfizer
Updated on 17 March 2021
body mass index
renal function
renal impairment
nephropathy
kidney function tests
renal function test

Summary

The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.

Description

This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06700841 after a single oral dose of 30 mg. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 days.

Details
Condition Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Healthy Volunteer, Peripheral Arterial Occlusive Disease, Renal Impairment, Brain Function, Renal Dysfunction, Impaired Renal Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, kidney insufficiency
Treatment PF-06700841
Clinical Study IdentifierNCT04260464
SponsorPfizer
Last Modified on17 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit
Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg
Normal, Severe, Moderate and Mild renal function at 2 Screening visits
Stable drug regimen

Exclusion Criteria

Renal transplant recipients
Urinary incontinence without catheterization
Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior to first dose
Known history of pulmonary embolism or recurrent deep vein thrombosis
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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